Chronic Neck PainCERV-MRI-USGNCT06747663
Reliability of MRI and Ultrasound in Cervical Epidural Needle Depth Estimation
An observational study of Chronic Neck Pain and Radicular Pain, run by Damla Yürük at 1 site in Turkey (Türkiye).
Trial summary
This study aims to evaluate the reliability of magnetic resonance imaging (MRI) and ultrasound (USG) in predicting needle depth during cervical epidural injections, compared to fluoroscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Neck Pain, Radicular Pain, Cervical Epidural Injection
- What is being tested?
- Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2025to Jul 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population includes adult patients aged 18 years and older, diagnosed with chronic cervical pain, and referred for cervical epidural steroid injection. Patients must be capable of providing informed consent and participating in follow-up assessments. Individuals with contraindications such as pregnancy, severe systemic infections, coagulopathy, known allergies to steroids or anesthetics, or prior cervical spine surgery are excluded.
Who may be able to join
- Age ≥ 18 years, Diagnosed with chronic cervical pain, Referred for cervical epidural steroid injection, Patients capable of providing informed consent.
Who cannot join
- Age < 18 years, Pregnancy or breastfeeding, History of coagulation disorders or use of anticoagulants, Severe systemic infections or local infections at the injection site, Known allergy to steroids or local anesthetics, Uncontrolled diabetes mellitus, Patients with spinal tumors or significant spinal deformities, Previous cervical spine surgery, Cognitive impairment preventing informed consent or follow-up participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ankara Etlik City Hospital
Ankara, Ankara, 06010
Damla Yürük, Associate Professor of Algolog, +905319932378, damlayuruk@hotmail.com
TAYLAN AKKAYA, PROFFESÖR, 095325569847, dr.taylanakkaya@gmail.com
About this study
Official title: Reliability of MRI and Ultrasound in Predicting Needle Depth During Cervical Epidural Injections: a Methodological Observational Study
This study aims to evaluate the reliability of magnetic resonance imaging (MRI) and ultrasound (USG) in predicting needle depth during cervical epidural injections, compared to fluoroscopy. The goal is to identify alternative imaging methods that reduce radiation exposure while maintaining procedural accuracy and patient safety.
Read the detailed description
Cervical epidural steroid injections (CESI) are commonly used to manage chronic neck and radicular pain. Accurate needle placement is critical for the success and safety of the procedure. Fluoroscopy is the standard method for guiding the needle; however, it exposes patients and clinicians to ionizing radiation.
This study compares pre-procedural MRI and USG measurements of needle depth with fluoroscopy-guided needle depth during CESI.
Primary Objective: Assess the agreement between MRI, USG, and fluoroscopy measurements of needle depth using intraclass correlation coefficients (ICC) within a ±0.3 cm tolerance.
Secondary Objectives: Evaluate the correlation between fluoroscopic lateral imaging frequency and radiation exposure.
The study is a methodological observational study conducted at Ankara Etlik City Hospital, involving adult patients undergoing CESI. Data will be collected retrospectively and prospectively for eligible participants.
- Being tested
- Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy
- Keywords
- Cervical Epidural Steroid Injection, Needle Depth Estimation, Ultrasound Guidance, MRI Guidance, Fluoroscopy, Radiation Exposure, Chronic Pain Management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Needle Depth Measurement Using MRI, Ultrasound, and FluoroscopyProcedure or surgery
This intervention involves cervical epidural steroid injection (CESI) for patients with chronic neck and radicular pain. Needle depth is measured pre-procedurally using MRI and ultrasound to predict the ideal needle placement. Fluoroscopy is used during the procedure to confirm and compare these measurements, aiming to evaluate the accuracy of imaging techniques and minimize radiation exposure.
| Study group | Role | What they receive |
|---|---|---|
| Cervical Epidural Injection Group | Participants undergoing cervical epidural injections for chronic neck and radicular pain. Needle depth will be measured pre-procedurally using MRI and ultrasound and compared with fluoroscopy-guided needle placement to assess reliability and radiation exposure. Receives: Procedure: Needle Depth Measurement Using MRI, Ultrasound, and Fluoroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections
The primary outcome measure evaluates the reliability and accuracy of pre-procedural needle depth measurements obtained using MRI and ultrasound imaging compared to intra-procedural fluoroscopy during cervical epidural steroid injections. The goal is to determine the concordance between these imaging techniques and assess their utility in reducing procedural radiation exposure.
Measured: 1 day (during the procedure)
Secondary outcomes (1)
Radiation Exposure During Cervical Epidural Steroid Injections
The secondary outcome measure assesses the level of radiation exposure (in mGy) experienced by patients and practitioners during cervical epidural steroid injections when fluoroscopy is used. Comparisons will be made to determine if the use of pre-procedural MRI or ultrasound reduces fluoroscopy duration and radiation exposure.
Measured: 1 day (during the procedure)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study startJan 2025 (estimated)
- Primary completionJun 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Damla Yürük
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Responsible party
- Sponsor-investigator, Damla Yürük, Diskapi Teaching and Research Hospital
- Investigators
- DAMLA YÜRÜK, Associate Professor of Algolog, Principal investigator, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747663
- Sponsor's protocol ID
- Ankara Etlik City Hospital
- Other IDs
- AEŞH-BADEK-2024-1133
- Acronym
- CERV-MRI-USG
- Status last verified
- Dec 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and data privacy regulations. Data sharing is not part of the current study plan
Publications
Pak MH, Lee WH, Ko YK, So SY, Kim HJ. Ultrasonographic measurement of the ligamentum flavum depth; is it a reliable method to distinguish true and false loss of resistance? Korean J Pain. 2012 Apr;25(2):99-104. doi: 10.3344/kjp.2012.25.2.99. Epub 2012 Apr 4.
PubMed 22514777
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reliability of MRI and Ultrasound in Predicting Needle Depth During Cervical Epidural Injections: a Methodological Observational Study
- ClinicalTrials.gov ID
- NCT06747663
- Acronym / sponsor ID
- CERV-MRI-USG / Ankara Etlik City Hospital
- Keywords
- Cervical Epidural Steroid Injection, Needle Depth Estimation, Ultrasound Guidance, MRI Guidance, Fluoroscopy, Radiation Exposure, Chronic Pain Management
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Damla YürükUniversity, hospital or other
- Collaborators
- Ankara Etlik City Hospital
- Study start
- Jan 2025 (estimated)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 24 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the reliability of magnetic resonance imaging (MRI) and ultrasound (USG) in predicting needle depth during cervical epidural injections, compared to fluoroscopy. The goal is to identify alternative imaging methods that reduce radiation exposure while maintaining procedural accuracy and patient safety.
Detailed description
Cervical epidural steroid injections (CESI) are commonly used to manage chronic neck and radicular pain. Accurate needle placement is critical for the success and safety of the procedure. Fluoroscopy is the standard method for guiding the needle; however, it exposes patients and clinicians to ionizing radiation.
This study compares pre-procedural MRI and USG measurements of needle depth with fluoroscopy-guided needle depth during CESI.
Primary Objective: Assess the agreement between MRI, USG, and fluoroscopy measurements of needle depth using intraclass correlation coefficients (ICC) within a ±0.3 cm tolerance.
Secondary Objectives: Evaluate the correlation between fluoroscopic lateral imaging frequency and radiation exposure.
The study is a methodological observational study conducted at Ankara Etlik City Hospital, involving adult patients undergoing CESI. Data will be collected retrospectively and prospectively for eligible participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cervical Epidural Injection Group | – | Procedure: Needle Depth Measurement Using MRI, Ultrasound, and FluoroscopyParticipants undergoing cervical epidural injections for chronic neck and radicular pain. Needle depth will be measured pre-procedurally using MRI and ultrasound and compared with fluoroscopy-guided needle placement to assess reliability and radiation exposure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes adult patients aged 18 years and older, diagnosed with chronic cervical pain, and referred for cervical epidural steroid injection. Patients must be capable of providing informed consent and participating in follow-up assessments. Individuals with contraindications such as pregnancy, severe systemic infections, coagulopathy, known allergies to steroids or anesthetics, or prior cervical spine surgery are excluded.
Key inclusion criteria (1 listed)
- Age ≥ 18 years, Diagnosed with chronic cervical pain, Referred for cervical epidural steroid injection, Patients capable of providing informed consent.
Key exclusion criteria (1 listed)
- Age < 18 years, Pregnancy or breastfeeding, History of coagulation disorders or use of anticoagulants, Severe systemic infections or local infections at the injection site, Known allergy to steroids or local anesthetics, Uncontrolled diabetes mellitus, Patients with spinal tumors or significant spinal deformities, Previous cervical spine surgery, Cognitive impairment preventing informed consent or follow-up participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Needle Depth Measurement Using MRI, Ultrasound, and FluoroscopyThis intervention involves cervical epidural steroid injection (CESI) for patients with chronic neck and radicular pain. Needle depth is measured pre-procedurally using MRI and ultrasound to predict the ideal needle placement. Fluoroscopy is used during the procedure to confirm and compare these measurements, aiming to evaluate the accuracy of imaging techniques and minimize radiation exposure. | Procedure or surgery | Cervical Epidural Injection Group |
Primary outcome
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections
Time frame: 1 day (during the procedure)
The primary outcome measure evaluates the reliability and accuracy of pre-procedural needle depth measurements obtained using MRI and ultrasound imaging compared to intra-procedural fluoroscopy during cervical epidural steroid injections. The goal is to determine the concordance between these imaging techniques and assess their utility in reducing procedural radiation exposure.
1 secondary outcome
Radiation Exposure During Cervical Epidural Steroid Injections
Time frame: 1 day (during the procedure)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2024.
- Background: PubMed 22514777Pak MH, Lee WH, Ko YK, So SY, Kim HJ. Ultrasonographic measurement of the ligamentum flavum depth; is it a reliable method to distinguish true and false loss of resistance? Korean J Pain. 2012 Apr;25(2):99-104. doi: 10.3344/kjp.2012.25.2.99. Epub 2012 Apr 4.
- Individual participant dataSharing planned: No. The individual participant data (IPD) will not be shared due to concerns regarding patient confidentiality and data privacy regulations. Data sharing is not part of the current study plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DAMLA YÜRÜK, Associate Professor of Algolog principal investigator
Ankara Etlik City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Neck Pain and Radicular Pain, run by Damla Yürük at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact DAMLA YÜRÜK, Associate Professor of Algolog (+905319932378, damlayuruk@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Needle Depth Prediction Using MRI and Ultrasound Compared to Fluoroscopy in Cervical Epidural Steroid Injections (time frame: 1 day (during the procedure)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06747663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2024.